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Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy

Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits, 1 visit
  • Time periods mentioned: 16 weeks, 4 months
  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The research study procedures include: screening for eligibility, study intervention, and evaluation of blood markers (blood draw), body composition, cardiorespiratory fitness, muscular strength, and surveys at study entry and follow-up visit."
  • "The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer. * Usual care - maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise program after 16 weeks."
  • "All participants will undergo two testing visits throughout the 16-weeks of the study period, with the exercise group part-taking in 1 additional testing visit at week 8 to assess aerobic fitness and muscular strength only."
  • "Participants will be on the research study for 4 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a 16-week exercise program, designed for Black men and using technology, can improve heart health risks, fitness, and well-being. It is for Black men with prostate cancer who receive androgen deprivation therapy (ADT), a hormone treatment. Men will be placed by chance into either a group doing aerobic and strength exercises or a group receiving usual care.

The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem. Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Identify as Black and be older than 18.
  • Have prostate cancer confirmed by a tissue test, whether it has spread or not.
  • Have received ADT for at least 1 month and plan to continue it for at least 4 more months when joining.
  • Have approval to exercise from your referring doctor or a certified clinical exercise specialist.
  • Have no health problem that could get worse with exercise, such as uncontrolled heart, lung, or metabolic disease, which affects how the body uses energy. Bone disease with a high risk of breaking a bone also counts, except cancer that has spread to bone.
  • Speak and complete written forms in English or Spanish.
  • Do no more than 60 minutes of planned, moderate or hard exercise each week.
  • Be willing and able to travel to Dana-Farber Cancer Institute for study measurements.

Who can't join

  • Are not receiving ADT.
  • Have an uncontrolled heart, lung, or metabolic disease that could get worse with exercise.
  • Do not speak English or Spanish.
  • Have a second diagnosis, except basal cell carcinoma, a type of skin cancer.
  • Do more than 60 minutes of planned, moderate or hard exercise each week.
  • Cannot travel to Dana-Farber Cancer Institute for study measurements.
  • The study doctor thinks you may not be able to follow the study's safety checks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question. * Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease * Histologically diagnosed of localized or metastatic prostate cancer * Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist and/or androgen receptor \[AR\] agonist/antagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment * Self-identify as Black * Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist * Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases * Speak English and/or Spanish * Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week * Willing to travel to DFCI for necessary data collection * Ability to communicate and complete written forms in English and/or Spanish Exclusion Criteria: * Are not receiving ADT (i.e., LHRH agonist/antagonist and/or AR agonist/antagonist) * Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise * Are not English or Spanish speaking * Patients with secondary diagnosis (with the exception of basal cell carcinoma) * Participate in more than 60 minutes of moderate or vigorous structured exercise/week * Unable to travel to DFCI for necessary data collection * May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.

Study sites (1)

MA